Use of the Leva Incontinence System in Treating Bladder Incontinence.

NCT03536923 | Completed Results FDA Device

• 1 other identifier: REN-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Conditions

Stress Urinary Incontinence

Keywords

Female

Outcome Measures

Primary Outcomes (1)

• Symptoms of Urinary Incontinence at Baseline and at 6 Weeks

  A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.

  6 weeks

Secondary Outcomes (3)

• Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.

  6 weeks

• Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)

  At 6 weeks

• Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)

  6 weeks

Study Arms (1)

Leva Arm

EXPERIMENTAL

Subjects will use the leva device twice daily to perform pelvic floor muscle exercises

Device: Leva Incontinence System For Pelvic Floor Muscle strengthening

Interventions

Leva Incontinence System For Pelvic Floor Muscle strengthening DEVICE

The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.

Leva Arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Gender Eligibility Details: Subject must have a vagina
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be female.
• Subjects must be capable of giving informed consent.
• Subjects should be at least 18 years of age and less than 89 years of age
• Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

You may not qualify if:

• Absence of a vagina.
• Positive drug or alcohol test at the screening visit.
• Post-menopausal defined as absence of a period for over 12 months.
• Pregnancy or being less than 12 months post-partum.
• Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
• Symptoms of stage II or greater pelvic organ prolapse.
• BMI \>31 kg/m2.
• Diagnosis of any neurological disorder.
• Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
• Prior pelvic radiation.
• Current or recurrent vaginal infections (\>three per year).
• Painful bladder syndrome, active or chronic pelvic pain.
• Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
• Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
• Currently taking medication to treat incontinence.

Sponsors & Collaborators

• Renovia, Inc.: lead

Study Sites (1)

New England Spine Center

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a single-arm, proof of concept trial. As such it lacks a comparison arm, planned in future studies.

Results Point of Contact

• Title: Chief Medical Officer, Dr. Samantha Pulliam
• Organization: Renovia, Inc

sjpulliam@renoviainc.com

866-735-8424

Study Officials

• Robert Rosenberg, MD

  New England Spine Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2018
• First Posted: May 25, 2018
• Study Start: April 10, 2017
• Primary Completion: August 12, 2017
• Study Completion: October 20, 2017
• Last Updated: December 12, 2018
• Results First Posted: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)